欧盟在CE的新法令立法架构下(NFL), 明确规范欧洲进口商、分销商与制造上的责任,并加强执行市场抽检要求。
- Regulation (EC) No 765/2008 on accreditation and market surveillance(认证和市场监督)
- Decision No 768/2008/EC on establishing a common framework for the marketing of products(该决议建立销售产品的通用架构)
- Regulation (EC) No 764/2008 to strengthen the internal market for a wide range of other products not subject to EU harmonization.
在以上新的欧盟法律规章与决议下,LVD Directive (2014/35/EU) and EMC Directive (2014/30/EU)正式发行,该指令将于2015-04-20生效,并且新增以下要求,
- 重新说明并定义制造商的义务 (Article 6 Obligations of manufacture )
- 重新说明并定义制造商与欧洲授权代表、进口商、分销商的责任与义务 (Article 7 Authorised representatives, Article 8 Obligations of importers, Article 9 Obligations of distributors)
- 技术文件需要包含 “充分的分析和评估风险”